The FDA’s top priority is to protect the public health. This priority includes making sure consumers know about products that put their health and safety at greatest risk, such as those claiming to prevent, diagnose, treat, mitigate, or cure serious diseases. For example, the agency has warned companies to stop selling CBD products they claim are intended to prevent, diagnose, treat, mitigate, or cure serious diseases such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes. While we have focused on these types of products, we will continue to monitor the marketplace for any product that poses a risk to public health, including those with dangerous contaminants, those marketed to vulnerable populations, and products that otherwise put the public health at risk.
The FDA recognizes the significant public interest in cannabis and cannabis-derived compounds, particularly CBD. However, there are many unanswered questions about the science, safety, and quality of products containing CBD. The agency is working on answering these questions through ongoing efforts including feedback from a recent FDA hearing and information and data gathering through a public docket.
Misleading, unproven, or false claims associated with CBD products may lead consumers to put off getting important medical care, such as proper diagnosis, treatment, and supportive care. For that reason, it’s important to talk to your doctor about the best way to treat diseases or conditions with available FDA-approved treatment options.
Some CBD Products are Being Marketed with Unproven Medical Claims and Could be Produced with Unsafe Manufacturing Practices
In addition to safety risks and unproven claims, the quality of many CBD products may also be in question. The FDA is also concerned that a lack of appropriate processing controls and practices can put consumers at additional risks. For example, the agency has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed. We are also investigating reports of CBD potentially containing unsafe levels of contaminants (e.g., pesticides, heavy metals, THC).
The FDA is actively working to learn more about the safety of CBD and CBD products, including the risks identified above and other topics, such as:
The FDA is committed to setting sound, science-based policy. The FDA is raising these safety, marketing, and labeling concerns because we want you to know what we know. We encourage consumers to think carefully before exposing themselves, their family, or their pets, to any product, especially products like CBD, which may have potential risks, be of unknown quality, and have unproven benefits.
The FDA is concerned that people may mistakenly believe that using CBD “can’t hurt.” The agency wants to be clear that we have seen only limited data about CBD’s safety and these data point to real risks that need to be considered. As part of the drug review and approval process for the prescription drug containing CBD, it was determined that the risks are outweighed by the benefits of the approved drug for the particular population for which it was intended. Consumer use of any CBD products should always be discussed with a healthcare provider. Consumers should be aware of the potential risks associated with using CBD products. Some of these can occur without your awareness, such as:
Emer Delaney BSc (Hons), RD has an honours degree in Human Nutrition and Dietetics from the University of Ulster. She has worked as a dietitian in some of London’s top teaching hospitals and is currently based in Chelsea.
Although the use of CBD is controversial, it does seem to be tolerated by most people. It has, however, caused hypotension and light-headedness in a small number of patients. As it does not contain the THC part of the cannabis plant, the oil will not induce a ‘high’.
What is CBD oil, is it legal in the UK and what are the benefits and risks of using it? We asked a dietitian to take a closer look at this food supplement.
Can I buy CBD oil safely?
One study reported reduced pain and muscle spasms in people with multiple sclerosis.
This is particularly important if you are experiencing any concerning symptoms, if you have any pre-existing conditions or if you are taking any medication including statins, blood thinning medication and calcium channel blockers.
Most large health food stores will stock ‘pure’ CBD oil. However, as it is classed as a ‘food supplement’ rather than a ‘medicinal product’, it isn’t regulated in the UK. This means you cannot know for sure that the product you buy contains the ‘active’ ingredients at the amounts listed on the label. Furthermore, the product may contain contaminants such as pesticides, heavy metals and other elements. For this reason, the NHS highlights there is no guarantee that these products will be of good quality or provide the intended health benefits.
For all the above uses of CBD, more human studies are needed to draw conclusive results.
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Dr. Smita Das, chair of the American Psychiatric Association’s Council on Addiction Psychiatry’s cannabis work group, does not recommend CBD for anxiety, PTSD, sleep or depression. With patients turning to these to unproven products, she is worried that they may delay seeking appropriate mental health care: “I’m dually concerned with how exposure to CBD products can lead somebody into continuing to cannabis products.”
Does CBD work?
A few drops of CBD oil in a mocha or smoothie are not likely to do anything, researchers contend. Doctors say another force may also be at play in people feeling good: the placebo effect. That’s when someone believes a drug is working and symptoms seem to improve.
While there is hope for treating other conditions with the plant extract, Epidiolex remains the only CBD-derived drug approved by the F.D.A. Most of the research on cannabidiol has been in animals, and its current popularity has outpaced science. “We don’t have the 101 course on CBD quite figured out yet,” said Ryan Vandrey, an associate professor of psychiatry and behavioral sciences at Johns Hopkins University School of Medicine.
“If you take pure CBD, it’s pretty safe,” said Marcel Bonn-Miller, an adjunct assistant professor at the University of Pennsylvania’s Perelman School of Medicine. Side effects in the Epidiolex trial included diarrhea, sleepiness, fatigue, weakness, rash, decreased appetite and elevated liver enzymes. Also, the safe amount to consume in a day, or at all during pregnancy, is still not known.
For students with generalized social anxiety, a four-minute talk, with minimal time to prepare, can be debilitating. Yet a small experiment in the journal Neuropsychopharmacology found that CBD seemed to reduce nervousness and cognitive impairment in patients with social anxiety in a simulated public speaking task.